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Drug

Dabigatran

Regulatory activity · MHRA
ClassThrombin inhibitorEmerging researchLate-stage development
RxNorm1546356ChEMBLCHEMBL48361UNIII0VM4M70GC
1
Research papers
3
Active clinical trials
Prothrombin
Primary target
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1 Study to Evaluate Relative Bioavailability and Food Effect of an ALG-097558 Tablet Formulation and the Drug-Drug Interaction Potential of ALG-097558 and Its Metabolite ALG-097730 in Healthy Volunteers

Clinical trial2026-05-18Results posted · ClinicalTrials.gov

Prospective Study on the Impact of Different Anti-thrombotic Therapies on Subclinical Leaflet Thickening and Its Temporal Dynamics in Transcatheter Bioprosthetic Aortic Valves (NOTION-4)

Clinical trial2026-04-01Primary completion · ClinicalTrials.gov

Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia

Clinical trial2026-03-20Results expected Q1 2030 · ClinicalTrials.gov

Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LT3001 Drug Product and Drug-Drug Interaction in Healthy Adult Subjects

Clinical trial2026-03-02Results posted · ClinicalTrials.gov

Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis: A Randomized Controlled Study

Clinical trial2026-01-31Primary completion · ClinicalTrials.gov

MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial

Clinical trial2025-01-31Primary completion · ClinicalTrials.gov

Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial

Clinical trial2024-11-30Completed · ClinicalTrials.gov

PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF)

Clinical trial2024-05-31Completed · ClinicalTrials.gov

An Open-Label Study to Investigate the Effect of Selpercatinib on the Pharmacokinetics of Dabigatran in Healthy Volunteers

Clinical trial2024-05-24Results posted · ClinicalTrials.gov

2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation.

Research2021-10-01Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology

Drug Safety Update: Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment

Regulatory2014-12-11MHRA

Drug Safety Update: Dabigatran (Pradaxa▼): risk of serious haemorrhage

Regulatory2014-12-11MHRA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Dabigatran
RxNorm CUI
1546356
ChEMBL ID
CHEMBL48361
UNII
I0VM4M70GC
Primary mechanism
Thrombin inhibitor
Regulatory jurisdictions
mhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Prothrombin
F2 · P00734
INHIBITORThrombin inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
MHRA
Total events
2
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2014-12-11Safety communicationSafety
Drug Safety Update: Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Dabigatran (Pradaxa▼): risk of serious haemorrhage
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

55 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
55
registered trials across all phases
LATEST COMPLETION 2025
3
Active studies
2
Recruiting
32
Late-stage (III+)
34
Completed
18
Discontinued
PHASE DISTRIBUTIONn = 55
Phase 117Phase 26Phase 2 / 32Phase 39Phase 414Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia

RecruitingPH IVMcGill University Health Centre/Research Institute of the McGill University Health Centren=3002030

Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial

CompletedPH IVCharite University, Berlin, Germanyn=9122024

Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin

CompletedPH IVUniversity of Sao Paulon=2002021

Effectiveness of Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Aortic and Mitral Valvular Atrial Fibrillation Patients

CompletedPH IVAsan Medical Centern=1202020

Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation

CompletedPH IVGeorg Nickenign=2002020

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1 Study to Evaluate Relative Bioavailability and Food Effect of an ALG-097558 Tablet Formulation and the Drug-Drug Interaction Potential of ALG-097558 and Its Metabolite ALG-097730 in Healthy Volunteers

CompletedPH INational Institute of Allergy and Infectious Diseases (NIAID)n=512025

Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial

CompletedPH IVCharite University, Berlin, Germanyn=9122024

PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF)

CompletedPH IIIImperial College Londonn=3192024

A PHASE 1, OPEN-LABEL, 3-TREATMENT, 6-SEQUENCE, 3-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF PF-07321332/RITONAVIR AND RITONAVIR ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY PARTICIPANTS

CompletedPH IPfizern=242021

Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LT3001 Drug Product and Drug-Drug Interaction in Healthy Adult Subjects

CompletedPH ILumosa Therapeutics Co., Ltd.n=652021

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of EDP-938 on the Pharmacokinetics of Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

CompletedPH IEnanta Pharmaceuticals, Incn=892021

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation.

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2021 · 670 cites
Recent papers

2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation.

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2021 · 670 cites
Major research themes2
Atrial Fibrillation1Stroke1
Journals, researchers & institutions
Top journals
  • Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology1
Leading researchers
  • Antz M1
  • Camm AJ1
  • Collins R1
  • Cornu P1
  • Desteghe L1
  • Haeusler KG1
  • Heidbüchel H1
  • Oldgren J1
Leading institutions
free-text, unnormalised
  • Antwerp University and University Hospital1
  • Cardiology Clinical Academic Group1
  • Hasselt University1
  • Hospital Braunschweig1
  • Research Group Clinical Pharmacology and Clinical Pharmacy1
  • School of Medicine1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Rivaroxaban

Studied across 2 of the same disease areas as Dabigatran in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.